Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021361
Company: SALIX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XIFAXAN RIFAXIMIN 200MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/25/2004 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21361_xifaxan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21361ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-361_Xifaxan.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/18/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021361s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021361Orig1s023ltr.pdf
01/06/2017 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/15/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/16/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/23/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/12/2014 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021361s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021361Orig1s013ltr.pdf
05/27/2015 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021361Orig1s012ltr.pdf
03/03/2010 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021361s011ltr.pdf
11/15/2010 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021361s009ltr.pdf
01/30/2007 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021361s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021361s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021361s023lbl.pdf
05/27/2015 SUPPL-12 Efficacy-New Indication Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbledt.pdf
03/12/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021361s013lbl.pdf
11/15/2010 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s009lbl.pdf
03/03/2010 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s011lbl.pdf
01/30/2007 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021361s006lbl.pdf
05/25/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21361_xifaxan_lbl.pdf

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